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One Step Cassette Style
PSA Test
Introduction
One
step PSA test is a rapid direct binding test for the
detection of prostate specific antigen (psa) in serum as an
aid in the diagnosis of prostate cancer. The test is based
on the principle of sandwich immunoassay for determination
of psa in serum. Monoclonal and polycional antibodies are
employed to identify psa specifically. This one step test is
very sensitive and only takes about 10-20 minutes. The
sensitivity of the test can reach to 4ug/l.
Specimen
collection
For
serum, collect blood into a container without anticoagulant.
Allow the blood to clot and separate the serum from the
clot. Use the serum for testing.
If the specimen cannot be
tested on the day of collection, store the serum specimen in
a refrigerator or freezer. Bring the specimens to room
temperature before testing. Do not freeze and thaw the
specimn repeatedly.
Test
procedure
1. Review
specimen collection instructions, test device, patients
samples and controls should be brought to room
temperature(18-30℃) prior to testing.
2. Remove the
test device from its protective pouch(bring the device to
room temperature before opening of the pouch to avoid
condensation of moisture on the membrane) .label the device
with patient or control identifications.
3. Draw sample
to the line marked on the pipettor (approximately 0.2ml ) .
Dispense entire contents into the sample well .
Alternatively, hold the pipette in a straight up and down
position - not at an angle. Dispense 6 drops (approximately
0.2ml ) of the specimen or control into the sample well
(diag. 1) for each sample or control , use a separate
pipettor and device.
4. Wait for
10-20 minutes and read results. And do not read results
after 30 minutes.

Interpretation of
results
Nega
Negative:
only one
pink colored band appears on the control regio (c)no
apparent band on the patient test region(t).
Positive:
in addition to a pink colored control band , a distinct Pink
colored control band will also appear in the patient test region(t)
Invalid
:
a total absence of color in both regions is an infication
of procedure error and/ or that test reagent deterioration
has occurred.
